(166 days)
Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.
The OrthoCor Knee System is a portable (battery operated) non-invasive shortwave diathermy medical device which applies electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i.e., by athermal means. The OrthoCor Knee System delivers the pulsed RF signal of 6.5±0.5µWs/cm3 to the tissue target via the inductive coupling with an applicator coil. OrthoPods are snapped into medial and lateral slots on the knee wrap to activate the system. Treatment may occur directly through dressings, clothing, casts, compression garments or supports. The OrthoCor device is substantial equivalent to the Ivivi Torino II device in parameters, treatment and power
Here's an analysis of the provided text regarding the OrthoCor Knee System and its acceptance criteria, focusing on the requested information:
This submission (K091996) is for a medical device (OrthoCor Knee System), not an AI/ML device. Therefore, many of the questions related to AI/ML specific criteria (such as training sets, ground truth methodology for AI, MRMC studies, and stand-alone algorithm performance) are not applicable to this document. The submission focuses on demonstrating substantial equivalence to a predicate device through bench testing of physical parameters rather than performance against a clinical ground truth.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the OrthoCor Knee System are based on its physical and electrical characteristics matching those of its predicate device, the Ivivi Torino II (K070541). The "reported device performance" here refers to the OrthoCor Knee System meeting these specified parameters during bench testing.
| Acceptance Criteria Category | Specific Criteria (Predicate Device Values) | OrthoCor Knee System Reported Performance |
|---|---|---|
| Technology | Deposit athermal RF energy in tissue | Deposit athermal RF energy in tissue |
| Anatomical Sites | Superficial soft tissues | Superficial soft tissues (knee) |
| Practitioner | Licensed physician/chiropractor | Licensed physician/chiropractor |
| Portability | Yes | Yes |
| Energy Deposition Method | Induction (coil applicator) | Induction |
| Carrier Frequency | 27.12 MHz | 27.12 MHz ± 5% |
| Burst Duration | 2 msec | 2 msec |
| Burst Frequency | 2 Hz | 2 Hz |
| Energy Deposited Per Pulse | 6.5 µWs/cm³ | 6.5 µWs/cm³ |
| Electrical Safety | Conforms with IEC 60601-1 | Conforms with IEC 60601-1 |
| Electromagnetic Safety | Conforms with IEC 60601-1-2 | Conforms with IEC 60601-1-2 |
| Power Required | Battery or Mains | 3V-4.2V DC (battery) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: This type of submission relies on bench testing of the device's physical and electrical properties, not on a clinical "test set" in the sense of patient data. The sample size would refer to the number of devices or components tested to ensure consistent output. This specific number is not provided in the document.
- Data Provenance: The data comes from bench testing performed by ORTHOCOR MEDICAL, Inc. It is not patient data from a specific country, nor is it described as retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This question is not applicable as the evaluation is based on objective physical/electrical measurements against established standards and predicate device specifications, not on expert-adjudicated ground truth from a clinical standpoint. Product conformity to standards like IEC 60601-1 would typically be verified by qualified engineers or testing facilities.
4. Adjudication Method for the Test Set
- This question is not applicable. There is no "adjudication method" in the traditional sense for this type of bench testing. The device's output parameters are measured and compared directly to the specified criteria and the predicate device's characteristics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a non-AI therapeutic device based on demonstrating substantial equivalence through technical specifications, not a clinical effectiveness study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not applicable. The OrthoCor Knee System is a physical medical device that delivers energy, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is the specified technical parameters and performance characteristics of the predicate device (Ivivi Torino II K070541), along with conformity to international electrical and electromagnetic safety standards (IEC 60601-1, IEC 60601-1-2). The device is deemed acceptable if its measured outputs and characteristics meet or fall within the acceptable range of these established benchmarks.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable. There is no "training set" as this is not an AI/ML device.
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.